<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2015091924089N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-02</date_registration>
      <primary_sponsor>Vice chancellor for research univercity of ahvaz</primary_sponsor>
      <public_title>Effect of cardiac rehabilitation on vascular function and glycemic condition in diabetic patients with Ischemic Heart disease</public_title>
      <acronym></acronym>
      <scientific_title>Effect of cardiac rehabilitation on endothelial function and HbA1c in diabetic patients with Ischemic Heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20422</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ischemic Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: cardiac rehabilitation, which includes a period of 1 hour exercise, including warm-up period of about 10 minutes, then 40 minutes of exercise with a treadmill, stationary bike or exercising arm (according to the protocol outlined monitoring each patient) and finally cooling period is for about 10 minutes. Cardiac monitoring is done during exercise. Total cardiac rehabilitation program is 24 sessions. Intervention 2: The control group included patients with a history of Cardiovascular disease who are treated with anti- ischemic drugs.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Mohammadirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 69, Zidane alley, Salman Farsi, Ramhormoz</address>
        <city>Ramhormoz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 4352 9921</telephone>
        <email>masoumemohammadirad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Reza Assareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3222 8037</telephone>
        <email>assareh@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Diabetic patients treated with oral blood glucose lowering drugs, with history of CABG or PCI, they refer for Cardiac Rehabilitation Center of Imam Khomeini Hospital.&#13;
Exclusion criteria: Smokers and those who have been smoking during the past 5 years are excluded؛&#13;
The reluctance of patients to participate in the study and not personal consent by the patient؛&#13;
Recurrent infarct during the study؛ Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications؛&#13;
Treatment of diabetes with insulin؛</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20, I21, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: cardiac rehabilitation, which includes a period of 1 hour exercise, including warm-up period of about 10 minutes, then 40 minutes of exercise with a treadmill, stationary bike or exercising arm (according to the protocol outlined monitoring each patient) and finally cooling period is for about 10 minutes. Cardiac monitoring is done during exercise. Total cardiac rehabilitation program is 24 sessions.</i_keyword>
      <i_keyword>The control group included patients with a history of Cardiovascular disease who are treated with anti- ischemic drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle Brachial Index. Timepoint: Before and after intervention. Method of measurement: By Vascular Screening Device VaSeraVS-1500N model.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before and after intervention. Method of measurement: HbA1c blood and laboratory use.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>METS. Timepoint: Before and after study. Method of measurement: The Duke questionnaire.</sec_outcome>
      <sec_outcome>Fasting Blood Suger. Timepoint: Before and after study. Method of measurement: Blood Sample.</sec_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Before and after study. Method of measurement: By Manometer.</sec_outcome>
      <sec_outcome>Glomerular filtration rate. Timepoint: Before and after study. Method of measurement: Cockcroft-Gault Equation.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before and after study. Method of measurement: The ratio of height to weight.</sec_outcome>
      <sec_outcome>Lipid Profil. Timepoint: Before and after study. Method of measurement: Blood Sample.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research univercity of ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-23</approval_date>
        <contact_name>Ethics Committee Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
